Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

NCT03695640 | Unknown Phase 4

• 1 other identifier: MgTKA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty.

Conditions

Knee Arthroplasty, Total; Postoperative Pain

Keywords

total knee arthroplasty; postoperative pain; continuous femoral nerve block; magnesium sulphate

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Score

  measurement of postoperative pain using Visual Analogue Score. Minimum: 0 Maximum: 10. Higher values represent more pain, hence lower values are better

  T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours

Secondary Outcomes (1)

• Analgesic consumption

  T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours

Study Arms (2)

Group L

ACTIVE COMPARATOR

continuous femoral nerve block with levobupivacaine

Procedure: continuous femoral nerve block

Group LM

EXPERIMENTAL

continuous femoral nerve block with levobupivacaine and magnesium sulfate

Drug: Magnesium Sulfate; Procedure: continuous femoral nerve block

Interventions

Magnesium Sulfate DRUG

Addition of magnesium sulfate as an adjuvant to levobupivacaine

Group LM

continuous femoral nerve block PROCEDURE

continuous nerve block with levobupivacaine for treatment postoperative pain

Group L; Group LM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for elective unilateral primary total knee arthroplasty

You may not qualify if:

• Patient refusal to enroll in the study
• Patient refusal of neuraxial anesthesia
• Existence of contraindications for neuraxial anesthesia
• Known history of allergy to any of the study drugs

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University Faculty of Medicine Hospital

Ankara, Balgat, 06510, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Albrecht E, Morfey D, Chan V, Gandhi R, Koshkin A, Chin KJ, Robinson S, Frascarolo P, Brull R. Single-injection or continuous femoral nerve block for total knee arthroplasty? Clin Orthop Relat Res. 2014 May;472(5):1384-93. doi: 10.1007/s11999-013-3192-3.

  PMID: 23928707 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Baturay K Kazbek, MD

  Ufuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baturay K Kazbek, MD

CONTACT

+903122044000; bkkazbek@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: randomized, controlled, prospective

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 15, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)